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A Study to Evaluate MAR002 for Acromegaly

9. september 2026 oppdatert av: Marea Therapeutics

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR002 in Participants With Acromegaly (TROUGH-2)

Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

MAR-202 is a randomized, multicenter, double-blind, placebo-controlled dose-range finding study.

After screening, participants who meet all eligibility criteria will be randomized to 1 of 3 active MAR002 regimens or matching placebo in a 3:1 ratio for a 10-week Treatment Period. During the Treatment Period, study drug (MAR002 or matching placebo) will be administered at study visits every 2 weeks (Q2W; Days 1, 15, 29, 43, and 57) followed then by a Follow-up Period before the End of Study (EOS) Visit on Week 16.

This study will aim to enroll a total of approximately 72 participants with acromegaly across 3 groups (Group 1: "untreated"; Group 2: "controlled on medical therapy"; Group 3: "uncontrolled on medical therapy").

Studietype

Intervensjonell

Registrering (Antatt)

72

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85013
        • Rekruttering
        • St. Joseph's Hospital and Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kevin Yuen
    • Ohio
      • Columbus, Ohio, Forente stater, 43201
        • Rekruttering
        • Endocrinology Associates, Inc
        • Hovedetterforsker:
          • Elena Christofides
        • Ta kontakt med:
    • Texas
      • San Antonio, Texas, Forente stater, 78258
        • Rekruttering
        • Consano Clinical Research
        • Hovedetterforsker:
          • Daniel Katselnik
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Willing to provide written informed consent and comply with study procedures as specified in this protocol and comply with study treatment.
  2. Age 18 to 75 years (inclusive) at screening with active acromegaly confirmed by an endocrinologist specialized in the care of pituitary patients. At a minimum, there must be documentation of a pituitary tumor (e.g., imaging evidence of a pituitary tumor by magnetic resonance imaging [MRI]/computerized tomography [CT] or histopathologic evidence of pituitary adenoma following pituitary surgery) and an elevated IGF-1 in the past.
  3. Participants receiving acromegaly medical therapy at screening (i.e., Group 2 and Group 3) may be enrolled if the regimen is considered stable by the Investigator and must agree to wash out acromegaly treatment, if applicable per protocol.
  4. Average serum IGF-1 level of ≥ 1.3 × ULN defined as the mean of 2 measurements obtained ≥ 1 week apart during Screening.
  5. Participants with hypothyroidism and adrenal insufficiency should have these hormone axes adequately replaced as judged by the Investigator.
  6. Weight ≥ 50 kg at screening.

Exclusion Criteria:

  1. History of hypersensitivity to monoclonal antibodies.
  2. Participation in any other investigational drug study and received the last dose of investigational drug within 60 days or 5 half-lives (whichever is longer) of SV1.
  3. History of severe allergic or anaphylactic reactions.
  4. History of malignancy within 5 years prior to screening other than successfully treated basal or squamous cell carcinoma or localized cervical carcinoma. Any carcinoma in situ is allowed if appropriately treated within 2 years prior to screening. Subjects with a history of malignancy ≥ 5 years prior to screening should be considered cured of their oncological disease.
  5. Pituitary surgery in the past 6 months prior to screening or any prior use of pituitary radiation therapy.
  6. Pituitary adenoma with concern for mass effect on the optic chiasm or other critical structures within the study period as per judgment of the Investigator.
  7. Poorly controlled diabetes mellitus, defined as having a hemoglobin A1c (HbA1c) ≥ 9.0%.
  8. Severe renal insufficiency (estimated glomerular filtration rate [eGFR by Chronic Kidney Disease Epidemiology Collaboration] < 30 mL/min/1.73 m2) or significant liver disease (including cirrhosis) prior to randomization.
  9. History or evidence of any of the following within the previous 12 months: myocardial infarction, cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), hospitalization for heart failure, or stroke or transient ischemic attack.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MAR002 Dose 1
Subcutaneous injection
Legemiddel: MAR002
Subcutaneous injection
Eksperimentell: MAR002 Dose 2
Subcutaneous injection
Legemiddel: MAR002
Subcutaneous injection
Eksperimentell: MAR002 Dose 3
Subcutaneous injection
Legemiddel: MAR002
Subcutaneous injection
Placebo komparator: Matched Placebo
Subcutaneous Placebo
Legemiddel: Placebo
Subkutan injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with TEAEs (treatment-emergent adverse events), SAEs (serious adverse events), and other laboratory endpoints
Tidsramme: Baseline to Week 16
To assess the safety and tolerability of multiple subcutaneous (SC) dose administrations of MAR002 in participants with acromegaly
Baseline to Week 16
Percent change from baseline in serum insulin-like growth factor 1 (IGF-1) levels as an average of Week 8 and Week 10
Tidsramme: Baseline to Week 10
To assess the effect of MAR002 on serum insulin-like growth factor 1 (IGF-1) levels in participants with acromegaly
Baseline to Week 10

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in ring size
Tidsramme: Baseline to Week 10
To explore the effects of MAR002 on acromegaly symptoms
Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by the Acromegaly Quality of Life (AcroQoL)
Tidsramme: Baseline to Week 10
To explore the effects of MAR002 on acromegaly symptoms
Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by Investigator assessment
Tidsramme: Baseline to Week 10
To explore the effects of MAR002 on acromegaly symptoms
Baseline to Week 10
Change from baseline in acromegaly symptoms as measured by the Acromegaly Symptom Diary (ASD)
Tidsramme: Baseline to Week 10
To explore the effects of MAR002 on acromegaly symptoms
Baseline to Week 10

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Marea Therapeutics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juli 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MAR-202

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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